Adjustable suture restriction system and method

ABSTRACT

A one-way knot pusher and/or locking device is provided and can be used for the adjustment of soft tissue anchoring components that create or improve continence. The device can be generally button- or disc-shaped and can include a carrier and a pin. When the device is pushed in the free sliding direction it acts as a knot pusher. However, when reversed the suture (e.g., the knot) jams or wedges inside of the cavity of the carrier, restricting or preventing motion in the opposite direction.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of, and claims priority to, U.S.patent application Ser. No. 14/061,580, filed on Oct. 23, 2013, entitled“ADJUSTABLE SUTURE RESTRICTION SYSTEM AND METHOD”, which, in turn,claims priority to U.S. Patent Application No. 61/717,317, filed on Oct.23, 2012, the disclosures of which are incorporated by reference hereinin their entirety.

FIELD OF THE INVENTION

The present invention relates to apparatus, tools and methods fortreating pelvic conditions and, more particularly, an adjustable suturerestriction system utilized to advance a component or part attached to asurgical suture.

BACKGROUND OF THE INVENTION

It has been reported that over 13 million American men and women of allages suffer from urinary and fecal incontinence. The social implicationsfor an incontinent patient include loss of self-esteem, embarrassment,restriction of social and sexual activities, isolation, depression and,in some instances, dependence on caregivers. Incontinence is the mostcommon reason for institutionalization of the elderly.

The urinary system consists of the kidneys, ureters, bladder andurethra. The bladder is a hollow, muscular, balloon-shaped sac thatserves as a storage container for urine. The bladder is located behindthe pubic bone and is protected by the pelvis. Ligaments hold thebladder in place and connect it to the pelvis and other tissue. Theurethra is the tube that passes urine from the bladder out of the body.The narrow, internal opening of the urethra within the bladder is thebladder neck. In this region, the bladder's bundled muscular fiberstransition into a sphincteric striated muscle called the internalsphincter. The urethra extends from the bladder neck to the end of thepenis. The male urethra is composed of three portions: the prostatic,bulbar and pendulus portions. The prostatic portion is the widest partof the tube, which passes through the prostate gland. The rectum is themost distal portion of the gastrointestinal tract. The exterior openingof the rectum is the anus. Fecal continence is related to control of theexterior sphincter and interior sphincter of the anus.

Urinary incontinence may occur when the muscles of the urinary systemare injured, malfunction or are weakened. Other factors, such as traumato the urethral area, neurological injury, hormonal imbalance ormedication side-effects, may also cause or contribute to incontinence.There are five basic types of incontinence: stress incontinence, urgeincontinence, mixed incontinence, overflow incontinence, and functionalincontinence. Stress urinary incontinence (SUI) is the involuntary lossof urine that occurs due to sudden increases in intra-abdominal pressureresulting from activities such as coughing, sneezing, lifting,straining, exercise and, in severe cases, even simply changing bodyposition. Urge incontinence, also termed “hyperactive bladder,”“frequency/urgency syndrome,” or “irritable bladder,” occurs when anindividual experiences the immediate need to urinate and loses bladdercontrol before reaching the toilet. Mixed incontinence is the mostcommon form of urinary incontinence. Inappropriate bladder contractionsand weakened sphincter muscles usually cause this type of incontinence.Mixed incontinence is a combination of the symptoms for both stress andurge incontinence. Overflow incontinence is a constant dripping orleakage of urine caused by an overfilled bladder. Functionalincontinence results when a person has difficulty moving from one placeto another. It is generally caused by factors outside the lower urinarytract, such as deficits in physical function and/or cognitive function.

SUI is generally thought to be related to hypermobility of the bladderneck or an intrinsic urethral sphincter defect. A variety of treatmentoptions are currently available to treat incontinence. Some of thesetreatment options include external devices, behavioral therapy (such asbiofeedback, electrical stimulation, or Kegal exercises), injectablematerials, prosthetic devices and/or surgery. Depending on age, medicalcondition, and personal preference, surgical procedures can be used tocompletely restore continence.

Conservative management of SUI can include lifestyle changes, such asweight loss, smoking cessation, and modification of intake of diureticfluids such as coffee and alcohol. Mid-urethral slings have beeneffective. One type of procedure, found to be an especially successfultreatment option for SUI in both men and women, is a sling and supportprocedure.

Fecal incontinence, like urinary incontinence, has proven to bechallenging to treat. Patients whose fecal incontinence is caused byexternal anal sphincter injury is treated surgically, as with asphincteroplasty. Other patients, though, are considered to haveneurogenic or idiopathic fecal incontinence, and efforts to treat thesepatients has been less successful. Various procedures, such as postanalrepair, total pelvic floor repair, muscle transposition techniques,dynamic graciloplasty, artificial sphincter procedures, and sacral nervestimulate on. Success has been limited, and the various treatmentmodalities can result in morbidity.

There is a desire for a minimally invasive yet highly effectivetreatment modality, tools and devices that can be used with minimal tono side effects for the treatment of both urinary and fecalincontinence.

SUMMARY OF THE INVENTION

The present invention can include surgical instruments, implantablearticles, and methods for urological applications, particularly for thetreatment of stress and/or urge urinary incontinence, fecalincontinence, and prolapse by implanting a paraurethral or otherconstraining or support device.

A one-way knot pusher device can be included to advance, e.g., in asingle direction, a component or part attached to a suture or likemember. This device can be useful for the adjustment of soft tissueanchoring components that support pelvic tissue to create continence. Itcan also be useful for any number of other applications where one-waytensioning is desired such as anchoring pelvic floor repair meshes forincontinence, prolapse, or hernias. The device can also be used forwound closure and orthopedic procedures such as muscle and tendonrepairs. The one-way knot pusher device is advantageous in that it canbe constructed as a very small part yet still provide high retentionstrength.

In one embodiment, the one-way knot pusher device is generallybutton-shaped and can be held against or abutting soft tissue to provideadjustable tensioning and support. The device can be constructed ofthree components: a knot carrier (e.g., clear polycarbonate), a pinmember (e.g., stainless steel), and a suture (e.g., 2-0 braided nylon).A cavity is formed 15 inside the carrier that is sized such that asuture passing through a suture aperture in the cavity can wrap aroundthe pin for subsequent tying into an overhand knot.

The suture enters the aperture at the face of the device that is towardthe free sliding direction, loops around the pin (e.g., into theaperture and under and around pin), and then is twisted through thesuture loop. Other types of knots can also be employed with the lock 20device. When the device is pushed in the free sliding direction it actsas a knot pusher. However, when reversed the suture (e.g., the knot)jams or wedges inside of the cavity of the carrier, restricting orpreventing motion in the opposite direction.

Embodiments of the present invention can include apparatus and methodsfor treating urinary incontinence, fecal incontinence, and other pelvicdefects or dysfunctions, in both males and females using one or moreimplants to reinforce the supportive tissue of the urethra, bladderneck, rectum, etc. The implants can be configured to engage and pull(e.g., pull up) or reposition the supportive tissue, such as theperineal membrane. The perineal membrane is the fibrous membrane in theperineum that intersects the urethra and vagina near the midurethralocation and can thus be stabilized or controlled in a manner that helpsrestore continence. As such, systems, methods and implants can beutilized to eliminate the need for mesh or other supportive structuresunder the urethra that is common with other incontinence slings. Theimplants can be shaped to facilitate such support, e.g., provided withanchoring end portions, barbs or other devices of many available shapesand configurations. One or more anchors or tissue engagement portionscan be employed to attach and stabilize the implants or devices totissue.

An anchoring element or portion, such as a medial or proximal anchor,can be fixed on each side of the urethra on the far side of a tissuelayer that is known to have relatively high strength and toughness. Incertain embodiments, the knot pusher device can also serve as the tissueanchor, while in others it is used in conjunction with a tissue anchor.

A second anchor device, such as a distal anchor or engagement device,can be placed in a lateral or superior position such that a connectionbetween the medial and lateral anchors (via a suture, mesh, wire or likeconnection) can provide tensile support for the urethra during stressevents. The distal anchor device can be fixated to, or around, thetendinous arch of the levator ani (white line), the Cooper's ligament,the obturator foramen, obturator internus, abdominal fascia,sacrospinous ligament, prepubic fascia or muscle, the pubic symphysiscartilage, or other stable anatomical structures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a one-way suture knot pusher or lockingdevice, in accordance with embodiments of the present invention.

FIG. 2 is a top view of a one-way suture knot pusher or locking device,in accordance with embodiments of the present invention.

FIGS. 3-5 are views of a one-way suture knot pusher or locking devicedeployed along a suture, in accordance with embodiments of the presentinvention.

FIG. 6 is a view of a one-way suture knot pusher or locking devicedeployed along a suture with a knot wedged in a cavity of the device tolimit movement in a second direction, in accordance with embodiments ofthe present invention.

FIG. 7 shows an implant system having a one-way suture knot pusher orlocking device deployed within the patient, in accordance withembodiments of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring generally to FIGS. 1-7, embodiments of the present inventioncan include apparatus and methods for treating urinary incontinence,fecal incontinence, and other pelvic defects or dysfunctions, in bothmales and females using one or more lateral implants to reinforce thesupportive tissue of the urethra, bladder neck, rectum, etc.

A one-way knot pusher device is provided and can be used for theadjustment of soft tissue anchoring components that create or improvecontinence. Further, the knot pusher device can be employed in a numberof other applications where one-way tensioning is desired, such asanchoring pelvic floor repair meshes for incontinence, prolapse, orhernias. The device can also be utilized for wound closure andorthopedic procedures, such as muscle and tendon repairs. The device isadvantageous in that it is a small component that can provide highretention strength in a wide variety of applications and procedures.

Referring generally to FIGS. 1-3, the one-way knot or suture lock device10 can be generally button- or disc-shaped and can include a carrier 12and a pin 14. In various embodiments, the device 10 or carrier 12 canassume other shapes, including rectangular, oval, square, or a myriad ofother shape constructs. The carrier 12 can include a cavity portion 16,and a suture aperture 18 extending therethrough. The aperture 18 can bedefined closely adjacent to the pin 14. The pin 14 can be provided tohave a level of rotational motion within its confinement in the carrier12, or the pin 14 can be stationary or fixed.

The cavity portion 16 can be defined in an extending platform 16 a, orotherwise defined in a portion of the carrier 12. The cavity 16 is sizedand shaped such that a suture passing through from the aperture 18 canwrap around the pin 14 and subsequently be tied into a simple overhandor other acceptable knot configuration. Further, the cavity 16 withinthe carrier 12 is sized in a manner that facilitates the desired one-waytravel. Relative to the center pin 14 diameter, in various embodiments,the clearance around the pin 14 can be approximately one suture width,and axially the space can be approximately two suture widths long. Theclearance may be slightly more or less than the described dimensions andproportions depending on the type of suture 20 used and the materialsfor the pin 14 and carrier 12. Other suture, cavity dimensions anddevice 10 component configurations and constructs can be employedwithout deviating from the scope of the present invention, depending onthe particular application and procedure requirements.

The suture 20 can follow and engage with the device 10 as shown in FIGS.3-4. While positions, directions, and like orientations for the suture20 are depicted with different shadings/hatchings, other configurationsand knot constructs can obviously be employed as well to provide thedisclosed sliding and locking features of the present invention. Thesuture 20 enters the aperture 18 at the face 12 a of the device 10 thatis toward the free sliding direction for segment A, loops around the pinfor segment B (e.g., into aperture 16, and under and around pin 14), andthen is twisted through the suture loop for segment C. Other types ofknots can also be employed with the lock device 10. When the device 10is pushed in the free sliding direction Sit acts as a knot pusher.However, when reversed the suture 20 (e.g., knot 21) jams or wedgesinside of the cavity 16 of the carrier 12, preventing motion in theopposite direction.

The carrier 12 can be constructed from nearly any rigid or semi-rigidmaterial including polymers, metals, epoxies, etc. The action of jammingthe suture 20 can be accomplished or further facilitated in certainembodiments by incorporating features such as ridges, barbs, surf acefeatures, or scales that favor sliding of the suture 20 in one directionand restriction or locking in the opposing direction. Moreover, suchfeatures could be added to either the carrier cavity 16 or the centerpin 14. The suture 20 can be a braided type material such as nylon orpolyester, but the device could also work with monofilament materials.

In certain embodiments, the device 10 can be positioned at the perinea!membrane or like anchoring positions at a location near the urethra, orother anchoring spots targeted to treat urinary or fecal incontinence ina patient.

As shown in FIG. 5, a pusher tube 40 can be used to adjust the tractionload on the device 10, against tissue, and can then be removed, followedby trimming of the suture 20 to conceal it within the superficialperineal pouch or like anatomical target or anchoring location. FIG. 6demonstrates the use of a device (e.g., tweezers, needle, scissors,clamp, etc.) in an attempt to reverse the direction of the device 10,with the knot 21 further wedging within the carrier 12 to restrict suchmovement in a direction opposite the free sliding direction S.

An embodiment of the device 10 in use to treat incontinence is shown inFIG. 7. One or more implant devices 30 can be configured to engage andpull (e.g., pull up) or reposition support tissue (e.g., paraurethral),such as the perinea! membrane PM, uterovaginal fascia, endopelvicfascia, or other anatomical features at which connective support of theurethra U can be established. The perineal membrane intersects theurethra and vagina V at the midurethra I distal location and can thus bestabilized or controlled in a manner that helps restore continence. Assuch, the implants can be utilized to eliminate the need for mesh orother supportive structures under the urethra that is common with otherincontinence slings. The implants can be shaped to facilitate suchsupport, e.g., provided with anchoring end portions, barbs or otherdevices of many available shapes, sizes and configurations, andextension members, including those disclosed in U.S. Patent PublicationNos. 2013/0023724, and 2013/0204075, which are incorporated herein byreference in their entireties.

In various embodiments, the one or more implants 30 can be placed instrategically located positions to pull up or otherwise tighten tissueand/or muscle lateral or otherwise intersecting or attached (directly orindirectly) with the urethra to generally stabilize the anatomicalstructure of the patient. Various systems, devices, structures,techniques and methods, alone or in combination, as disclosed in U.S.Patent Publication Nos. 7,500,945, 7,407,480, 7,351,197, 7,347,812,7,303,525, 7,025,063, 6,911,003, 6,691,711, 6,648,921, 6,612,977,6,802,807, 2002/0161382, 2002/0147382, 2002/151762, 2004/0039453,2008/0057261, 2008/0045782, 2010/0105979, 2011/0144417, and 2011/0201876and International PCT Publication Nos. WO 2008/057261 and WO2007/097994, can be employed with the present invention, with theabove-identified disclosures being incorporated herein by reference intheir entirety. The devices or structures described herein can beemployed or introduced into the pelvic region of the patienttransvaginally, percutaneously or in any other manner known by those ofordinary skill in the art.

One or more opposing anchors 34, 36 or tissue engagement portions can beemployed to attach and stabilize the implants to the tissue, as well asprovide selective adjustment. The anchors or engagement portions can beconfigured to engage soft tissue and can include various barbs, tines,serrated edges, extending fibers, or other similar structural feature topromote tissue fixation. The anchors can be implanted in a directionlateral from the urethra U. The anchors can generally be small enough tobe unnoticeable by both the patient and the patient's sexual partner.The anchors and other devices and components of the system may beconstructed from various biocompatible materials, such as known polymersand metals that promote long-term resilience, or other materials knownto those skilled in the art.

In various embodiments, the lateral or distal anchor devices 36 can bedirected for engagement with tissue distal the medial or proximalanchors 34 at target sites such as the obturator foramen, obturatorinternus muscle, sacrospinous ligament, prepubic fascia or muscle,abdominal fascia, rectus fascia, puboprostatic ligament, the tendinousarch of the levator ani, the Cooper's ligament, and the pubic symphysis.

Various procedural steps or methods can be used to deploy the implant ofthe present invention. In one embodiment, the device 10 is the medialanchor 34 and is operatively connected to the distal anchor(s) 36 viaone or more sutures 20. The device 10 is implanted into tissue, a needleis withdrawn, the lateral (e.g., obturator) anchor 36 is delivered andimplanted, and the connecting suture 20 is properly tensioned betweenthe anchors using the one-way knot pusher feature of the device 10 toprovide proper support. In other embodiments, the device 10 is used inconjunction with an anchor, such as the medial anchor 34.

The systems, their various components, structures, features, materialsand methods of the present invention may have a number of suitableconfigurations as shown above. Various methods and tools forintroducing, deploying, anchoring and manipulating implants or to treatincontinence and prolapse as disclosed in the previously-incorporatedreferences are envisioned for use with the present invention as well.

A variety of materials may be used to form portions or components of theimplants and devices, including Nitinol, polymers, elastomers, porousmesh, thermoplastic elastomers, metals, ceramics, springs, wires,plastic tubing, and the like. The systems, components and methods mayhave a number of suitable configurations known to one of ordinary skillin the art after reviewing the disclosure provided herein.

All patents, patent applications, and publications cited herein arehereby incorporated by reference in their entirety as if individuallyincorporated, and include those references incorporated within theidentified patents, patent applications and publications.

Obviously, numerous modifications and variations of the presentinvention are possible in light of the teachings herein. It is thereforeto be understood that within the scope of the appended claims, theinvention may be practiced other than as specifically described herein.

What is claimed is:
 1. A surgical suture restriction system, comprising:a carrier having a base portion, a cavity portion, a pin disposed withinthe cavity portion, and a suture aperture; at least one sutureinsertable through the suture aperture and around the pin within thecavity portion to define a suture knot; and wherein the carrier is freeto slide in a first direction along a length of the at least one sutureand the knot engages within the cavity to restrict movement of thecarrier in a direction opposite the first direction.
 2. The system ofclaim 1, wherein the cavity portion is defined in an extended platformportion of the carrier.
 3. The system of claim 1, wherein the pin isfixed.
 4. The system of claim 1, wherein the suture knot is an overhandknot.
 5. The system of claim 1, wherein the at least one suture is abraided material.
 6. The system of claim 1, further including a pushertube to engage with and slide the carrier in the first direction.
 7. Thesystem of claim 1, wherein the carrier is generally button-shaped. 8.The system of claim 1, wherein the carrier is constructed of a generallyrigid polymer material.
 9. The system of claim 1, wherein the cavityportion is defined in an extended platform portion of the carrier andthe pin extends through the extended platform portion.
 10. The system ofclaim 9, wherein the base portion is generally cylindrical and theextended platform portion is generally rectangular.
 11. A surgicalanchor and suture restriction system, comprising: one or more firstdistal anchors; a carrier having a base portion, a cavity portion, a pindisposed within the cavity portion, and a suture aperture; at least onesuture operably connected and extending between the one or more firstdistal anchors and the carrier, the at least one suture insertablethrough the suture aperture and around the pin within the cavity portionto define a suture knot; and wherein the carrier is free to slide in afirst direction along a length of the at least one suture toward the oneor more first distal anchors and the knot engages within the cavity torestrict movement of the carrier in a direction opposite the firstdirection.
 12. The system of claim 11, wherein the cavity portion isdefined in an extended platform portion of the carrier.
 13. The systemof claim 11, wherein the pin is fixed.
 14. The system of claim 11,wherein the suture knot is an overhand knot.
 15. The system of claim 11,wherein the at least one suture is a braided material.
 16. The system ofclaim 11, further including a pusher tube to engage with and slide thecarrier in the first direction.
 17. The system of claim 11, wherein thecarrier is constructed of a generally rigid polymer material.
 18. Thesystem of claim 11, wherein the cavity portion is defined in an extendedplatform portion of the carrier and the pin extends through the extendedplatform portion.
 19. The system of claim 18, wherein the base portionis generally cylindrical and the extended platform portion is generallyrectangular.